Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.

NCT00932295 | Completed Phase 1

• 3 other identifiers: HM11820R01CA103827R01CA120142
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.

Conditions

Smoking

Keywords

tobacco; cigarette; nicotine

Outcome Measures

Primary Outcomes (1)

• Plasma nicotine concentration (ng/ml)

  baseline, 5, 15, 30, and 45 minutes post-use

Secondary Outcomes (2)

• Heart rate

  continuous

• Withdrawal suppression (subjective measure)

  baseline and 5, 15, 30, and 45 minutes post-use

Study Arms (4)

Own brand cigarette

ACTIVE COMPARATOR

10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)

Other: OB

Sham smoking

SHAM COMPARATOR

10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)

Other: Sham smoking

Electronic cigarette Version One C7

EXPERIMENTAL

10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)

Other: CROWN SEVEN

Electronic cigarette version 2: NJ

EXPERIMENTAL

10 puffs from a so-called "electronic cigarette" named NJOY (16 mg cartridge; 30 second inter puff interval)

Other: NJOY

Interventions

OB OTHER

10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)

Own brand cigarette

Sham smoking OTHER

10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)

Sham smoking

CROWN SEVEN OTHER

10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)

Electronic cigarette Version One C7

NJOY OTHER

10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)

Electronic cigarette version 2: NJ

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy, between 18 and 55 years of age, and report a cigarette intake of \> 15 cig/day for at least 1 year. They must provide an afternoon screening CO level of \> 15 ppm at intake. They must also provide a urine sample for cotinine analysis, and receive a result of at least 4 on the urine immunoassay test strip scale (possible range = 0-6) at intake.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control. 2010 Oct;19(5):367-73. doi: 10.1136/tc.2008.028993. Epub 2009 Apr 2.

  PMID: 19346218 BACKGROUND

• Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res. 2008 Sep;10(9):1441-8. doi: 10.1080/14622200802323258.

  PMID: 19023835 BACKGROUND

• Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res. 2008 Mar;10(3):417-21. doi: 10.1080/14622200801901880.

  PMID: 18324559 BACKGROUND

• Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res. 2006 Dec;8(6):727-38. doi: 10.1080/14622200600789585.

  PMID: 17132520 BACKGROUND

• Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control. 2002 Dec;11(4):376-8. doi: 10.1136/tc.11.4.376.

  PMID: 12432165 BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thomas Eissenberg, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

US (1)